Fluocinonide (Page 2 of 2)

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning Hypertrichosis Maceration of the Skin
Itching Acneiform Eruptions Secondary Infection
Irritation Hypopigmentation Skin Atrophy
Dryness Perioral Dermatitis Striae
Folliculitis Allergic Contact Dermatitis Miliaria

To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Fluocinonide Cream, USP 0.05% (Emulsified Base) is generally applied to the affected area as a thin film from two to four times daily, as needed.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0115-1705-52), 30 g (NDC 0115-1706-45) and
60 g (NDC 0115-1707-58) Tubes.

Store at controlled room temperature 15°-30°C (59°-86°F). Do not refrigerate.

Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080

Distributed by:
Impax Generics
Hayward, CA 94544
1933-01

GW 7140
Issued 08/2016
8-0664IMLNC1

PRINCIPAL DISPLAY PANEL — 0.05%, 15 G CREAM CARTON

NDC 0115-1705-52

15 g

Carton 15 g
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.05%, 30 G CREAM CARTON

NDC 0115-1706-45

30 g

Carton 30 g
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.05%, 60 G CREAM CARTON

NDC 0115-1707-58

60 g

Carton 60 g
(click image for full-size original)

FLUOCINONIDE fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1705
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide (Fluocinonide) Fluocinonide 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Cetyl Alcohol
Anhydrous Citric Acid
Mineral Oil
Polysorbate 60
Propylene Glycol
Water
Sorbitan Monostearate
Stearyl Alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1705-52 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0115-1705-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074204 03/21/2016
FLUOCINONIDE fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1706
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide (Fluocinonide) Fluocinonide 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Cetyl Alcohol
Anhydrous Citric Acid
Mineral Oil
Polysorbate 60
Propylene Glycol
Water
Sorbitan Monostearate
Stearyl Alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1706-45 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0115-1706-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074204 03/21/2016
FLUOCINONIDE fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1707
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide (Fluocinonide) Fluocinonide 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Cetyl Alcohol
Anhydrous Citric Acid
Mineral Oil
Polysorbate 60
Propylene Glycol
Water
Sorbitan Monostearate
Stearyl Alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1707-58 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (0115-1707-58)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074204 03/21/2016
Labeler — Impax Generics (079832487)
Registrant — G&W Laboratories, Inc. (001271188)
Establishment
Name Address ID/FEI Operations
G&W Laboratories, Inc. 001271188 manufacture (0115-1705), manufacture (0115-1706), manufacture (0115-1707)

Revised: 10/2016 Impax Generics

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.